- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01335516
Follow-up of Glypressin (Terlipressin) Clinical Efficacy in the Treatment of Bleeding Oesophageal Varices
Terlipressin is an effective and safe treatment for bleeding caused by rupture of oesophageal varices, which are life-threatening complications of liver cirrhosis.
Oesophageal varices are abnormal dilatation of veins occurring in the lower oesophagus, which can develop in patients with cirrhosis. Bleeding caused by rupture of these varices is a life-threatening complication with mortality between 20-50%.
Such bleeding can be treated with drug therapy and/or endoscopic; endoscopic therapy consists of a flexible tube equipped with a camera at the terminal end, allowing for visualizing and treating the oesophageal varices.
In this study, investigators will evaluate the safety and efficacy of terlipressin - Glypressin 1 mg, powder and solvent for solution for injection.
The non-interventional observational study "Follow-up of Glypressin (terlipressin) clinical efficacy in the treatment of bleeding oesophageal varices" aims to demonstrate that administration of Glypressin (terlipressin 1 mg) controls the bleeding in such patients.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Mureş
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Târgu Mureş, Mureş, Romania
- Emergency County Hospital - Surgery Clinic No.1
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Eligible patients that present an important upper gastrointestinal bleeding, being suspected or diagnosed of liver cirrhosis, with bleeding oesophageal varices visualized endoscopically.
(An important upper gastrointestinal bleeding is one requiring at least 2 units/24h of transfused blood).
Exclusion Criteria:
- Septic shock
- Patients with recent history of coronary insufficiency
- Uncontrolled arterial hypertension
- Chronic respiratory failure
- Symptomatic arteritis
- Chronic renal failure
- Pregnant women
- Hypersensitivity to terlipressin
- Patients with body weight below 55 kg
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To evaluate the clinical efficacy of Glypressin: measured by rapid control of heamorrhage; reduced mortality post-haemorrhage
Time Frame: Up to 6 months
|
Vital signs (blood pressure, heart rate, and body temperature) and routine safety lab analysis
|
Up to 6 months
|
To evaluate the safety profile of Glypressin: measured by number of patients with adverse events
Time Frame: Up to 6 months
|
Up to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To evaluate/monitor the ease of administration in ER
Time Frame: Up to 6 months
|
Easiness of use in ER (easy to reconstitute, easy to administer, flexible dosage)
|
Up to 6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Gastrointestinal Diseases
- Liver Diseases
- Esophageal Diseases
- Hypertension, Portal
- Hemorrhage
- Esophageal and Gastric Varices
- Gastrointestinal Hemorrhage
- Varicose Veins
- Antihypertensive Agents
- Vasoconstrictor Agents
- Terlipressin
Other Study ID Numbers
- FE999908 CS04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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